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EIT

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Alias Born 05/09/2017

EIT

Re: None

Tuesday, 05/14/2019 11:25:51 PM

Tuesday, May 14, 2019 11:25:51 PM

Post# of 140464
Highlights M&A

1) New Q1 2020 milestone - a) Ongoing software development and implementation and b) Planning and preparation for manufacturing and commercialization. Cost 8 million.
2) The Company had $23,610,440 of cash and cash equivalents on hand. No mention of how far current cash will take us.
3) the Company believes that it will need to raise approximately $35 million to fund it operations to the end of the first quarter of 2020.
4) The company will continue to explore alternative sources in order to minimize dilutive effects, including strategic partnerships, private placements and debt.
5) The Company recently updated its Milestone table with the expectation that the submittal of its IDE application to the FDA would take place early during the third quarter 2019 following successful completion of prerequisite animal and cadaver studies during the second quarter.
6) The recruitment of surgeons from multiple hospital sites has been initiated and will be necessary to perform the surgeries. Each of these sites will require approval of their independent Institutional Review Board (“IRB”) to approve the studies.
7) During the second and third quarters of 2019, the Company expects to complete the recruitment of surgeons and hospitals for the studies, secure IDE approval by the FDA and approvals by the IRB of each hospital, in preparation for the confirmatory human studies planned for completion during the fourth quarter.